Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia

October 26, 2021 updated by: Ghada Mohamed Bahy, Sohag University
This study aims at determining clinical presentations and outcomes of patients with covid-19 pneumonia and also follow up of patients for up to 6 months to detect possibility of post covid fibrosis

Study Overview

Detailed Description

According to the World Health Organization (WHO), the emergence of viral diseases represents a serious public health risk. In the past two decades, several epidemics caused by viruses such as the severe acute respiratory syndrome coronavirus (SARS-CoV) from 2002 to 2003, and H1N1 influenza in 2009, and the Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012 have been described which have had a significant impact on global health. Since being declared a global pandemic by the WHO, SARS-CoV-2, the virus responsible for COVID-19 has spread to 223 countries with more than 178 million confirmed cases, and more than 3.8 million deaths reported worldwide. The U.S. experienced the highest number of SARS-CoV-2 infections and COVID-19 related deaths followed by Brazil and India.

In fact, COVID-19 was the third leading cause of death in the U.S. in 2020 after heart disease and cancer, with approximately 375,000 death reported . As of 22 June 2021, the Alpha(B.1.1.7) variant has spread to 170 countries, the Beta (B.1.351) variant has been reported in 119 countries, the Gamma (P.1) variant has been detected in 71 countries and the Delta variant(B.1.617.2) has spread to 85 countries around the world based on the weekly epidemiological update by the WHO . The WHO's current estimate of the global case fatality rate for COVID-19 is 2.2%. However, the case fatality rate is affected by factors that include age, underlying preexisting conditions, and severity of illness and significantly varies between countries.

The common clinical features of COVID-19 pneumonia in adults include fever, dry cough, sore throat, headache, fatigue, myalgia and breathlessness . The disease manifestations in the infected patients range from mild pneumonia (81%) to moderate pneumonia (hypoxia requiring hospitalization, 14%), and critical illness (leading to invasive mechanical ventilation, multiorgan dysfunction and possibly death, 5%). The risk of death depends on age, underlying comorbidities and severity of the disease, increasing up to 49% in critically ill patients.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with covid-19 pneumonia

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients with covid-19 pneumonia confirmed by:

Reverse transcription polymerase chain reaction Or pattern of covid-19 in computed tomography (CT) scan ( ground-glass opacity indicative of pneumonia on CT, opinion on consolidation, etc) with laboratory investigations

Exclusion Criteria:

  1. Patients not confirmed to be covid-19 with PCR or radiologically.
  2. Patients who are diagnosed as bacterial pneumonia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post covid fibrosis
Time Frame: Six month
Possibility of occurrence of post covid fibrosis by follow up of patients for up to 6 month
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hamdy A Mohammadeen, Ass.prof, Sohag University
  • Study Chair: Mona T Hussen, Ass.prof, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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